NOBIVAC® RABIES

FOR ANIMAL USE ONLY

Only for use by or under the supervision of persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para-veterinary Professions Act, 1982 (Act no. 19 of 1982).

INDICATIONS

For the active immunisation of healthy dogs, cats, cattle, sheep, goats and horses against rabies.

Nobivac^® Rabies may be used to reconstitute the freeze-dried canine vaccines and may be administered in combination with Nobivac^® Lepto (G2200).

Vaccination leads to a high peak level within 3 weeks, followed by a more or less constant level, sufficiently high to provide protection.

COMPOSITION

The vaccine is an inactivated culture of rabies virus, cloned out of strain Pasteur RIV. The virus is grown on the BHK-21 clone CT cell-line and inactivated with beta-propiolactone. It is presented as an aqueous aluminium phosphate suspension.

Each vial of 1 dose or 10 doses of 1 mℓ each contains: Inactivated rabies antigen suspension with a potency per dose of ≥ 2,0 i.u. (Ph.Eur. Method) with 0,3 % aluminium phosphate as adjuvant, glycine as a buffer and 0,1 mg thiomersal as preservative.

TARGET SPECIES

Dogs, cats, cattle, sheep, goats and horses.

STORAGE

• Store in the dark between 2 °C and 8 °C.
• Do not freeze.
• Protect from direct sunlight.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
• Allow the vaccine to gradually reach room temperature (20 °C to 25 °C) prior to use.
• In-use shelf-life: For the multi-dose vials, broached vials should be used within 1 working day.

WARNINGS

• Avoid intravenous injection.
• After subcutaneous administration, occasionally a transient palpable nodule may occur at the site of injection.
• Accidental self-injection may lead to a severe local allergic reaction. Consult a physician and make this insert available.
• Do not store partially used containers for future use.
• The entire contents of multi-dose vials should be used within 1 working day.
• Dispose of any unused vaccine and all empty vaccine containers according to local waste disposal regulations after vaccination.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected seek veterinary advice and inform the registration holder.

PRECAUTIONS

• Vaccinate healthy animals only.
• Observe aseptic precautions. Ensure that vaccination equipment (needles, syringes etc.) are clean and sterile prior to use.
• As with all vaccines, hypersensitivity or anaphylactic reactions may occur.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Shake well before use.
• Administer 1 mℓ via subcutaneous or intramuscular injection.

Vaccination Programme

	Dogs/Cats	Cattle/Sheep/Goats/Horses
* Primary vaccination at an age of more than	3 months	6 months
** Revaccination every	3 years	2 years

• Vaccination leads to a high peak level within 3 weeks followed by a more or less constant level, sufficiently high to provide protection.

*      Primary vaccination may be administered at an earlier age, but then a repeat vaccination must be given at the age of 3 months.

**    Recommended vaccination interval is based upon results from challenge experiments. Local regulations in force may require earlier revaccinations.

• Results from serological investigations indicate that vaccination of sheep, goats and foxes provide protection for at least 1 year.

PRESENTATION

The vials are of hydrolytical Type I glass (Ph.Eur.) and are closed with halogenated butyl rubber stoppers (Ph.Eur.) and sealed with coded aluminium caps.

Vials are packed in in polyethylene terephthalate (PET) trays containing 10 or 50 single dose or 10 vials of 10 doses.

DATE OF PUBLICATION OF THIS PACKAGE INSERT

26 February 2015

Zimbabwe Reg. No. E91/80.23.10/9287 Pharmacological classification: 802310 Distribution category: VMGD